API Suppliers
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Listed Suppliers
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U.S. Medicaid
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PharmaCompass offers a list of Nilotinib API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Nilotinib manufacturer or Nilotinib supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Nilotinib manufacturer or Nilotinib supplier.
PharmaCompass also assists you with knowing the Nilotinib API Price utilized in the formulation of products. Nilotinib API Price is not always fixed or binding as the Nilotinib Price is obtained through a variety of data sources. The Nilotinib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A nilotinib hydrochloride dihydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of nilotinib hydrochloride dihydrate, including repackagers and relabelers. The FDA regulates nilotinib hydrochloride dihydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. nilotinib hydrochloride dihydrate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of nilotinib hydrochloride dihydrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A nilotinib hydrochloride dihydrate supplier is an individual or a company that provides nilotinib hydrochloride dihydrate active pharmaceutical ingredient (API) or nilotinib hydrochloride dihydrate finished formulations upon request. The nilotinib hydrochloride dihydrate suppliers may include nilotinib hydrochloride dihydrate API manufacturers, exporters, distributors and traders.
click here to find a list of nilotinib hydrochloride dihydrate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A nilotinib hydrochloride dihydrate DMF (Drug Master File) is a document detailing the whole manufacturing process of nilotinib hydrochloride dihydrate active pharmaceutical ingredient (API) in detail. Different forms of nilotinib hydrochloride dihydrate DMFs exist exist since differing nations have different regulations, such as nilotinib hydrochloride dihydrate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A nilotinib hydrochloride dihydrate DMF submitted to regulatory agencies in the US is known as a USDMF. nilotinib hydrochloride dihydrate USDMF includes data on nilotinib hydrochloride dihydrate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The nilotinib hydrochloride dihydrate USDMF is kept confidential to protect the manufacturer’s intellectual property.
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In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a nilotinib hydrochloride dihydrate Drug Master File in Korea (nilotinib hydrochloride dihydrate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of nilotinib hydrochloride dihydrate. The MFDS reviews the nilotinib hydrochloride dihydrate KDMF as part of the drug registration process and uses the information provided in the nilotinib hydrochloride dihydrate KDMF to evaluate the safety and efficacy of the drug.
After submitting a nilotinib hydrochloride dihydrate KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their nilotinib hydrochloride dihydrate API can apply through the Korea Drug Master File (KDMF).
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A nilotinib hydrochloride dihydrate CEP of the European Pharmacopoeia monograph is often referred to as a nilotinib hydrochloride dihydrate Certificate of Suitability (COS). The purpose of a nilotinib hydrochloride dihydrate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of nilotinib hydrochloride dihydrate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of nilotinib hydrochloride dihydrate to their clients by showing that a nilotinib hydrochloride dihydrate CEP has been issued for it. The manufacturer submits a nilotinib hydrochloride dihydrate CEP (COS) as part of the market authorization procedure, and it takes on the role of a nilotinib hydrochloride dihydrate CEP holder for the record. Additionally, the data presented in the nilotinib hydrochloride dihydrate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the nilotinib hydrochloride dihydrate DMF.
A nilotinib hydrochloride dihydrate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. nilotinib hydrochloride dihydrate CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
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A nilotinib hydrochloride dihydrate written confirmation (nilotinib hydrochloride dihydrate WC) is an official document issued by a regulatory agency to a nilotinib hydrochloride dihydrate manufacturer, verifying that the manufacturing facility of a nilotinib hydrochloride dihydrate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting nilotinib hydrochloride dihydrate APIs or nilotinib hydrochloride dihydrate finished pharmaceutical products to another nation, regulatory agencies frequently require a nilotinib hydrochloride dihydrate WC (written confirmation) as part of the regulatory process.
click here to find a list of nilotinib hydrochloride dihydrate suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing nilotinib hydrochloride dihydrate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for nilotinib hydrochloride dihydrate API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture nilotinib hydrochloride dihydrate as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain nilotinib hydrochloride dihydrate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a nilotinib hydrochloride dihydrate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of nilotinib hydrochloride dihydrate suppliers with NDC on PharmaCompass.
nilotinib hydrochloride dihydrate Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of nilotinib hydrochloride dihydrate GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right nilotinib hydrochloride dihydrate GMP manufacturer or nilotinib hydrochloride dihydrate GMP API supplier for your needs.
A nilotinib hydrochloride dihydrate CoA (Certificate of Analysis) is a formal document that attests to nilotinib hydrochloride dihydrate's compliance with nilotinib hydrochloride dihydrate specifications and serves as a tool for batch-level quality control.
nilotinib hydrochloride dihydrate CoA mostly includes findings from lab analyses of a specific batch. For each nilotinib hydrochloride dihydrate CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
nilotinib hydrochloride dihydrate may be tested according to a variety of international standards, such as European Pharmacopoeia (nilotinib hydrochloride dihydrate EP), nilotinib hydrochloride dihydrate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (nilotinib hydrochloride dihydrate USP).